Lunaderm

Approved Indications:

• Tinea pedis (athlete’s foot) caused by Trichophyton rubrum and Epidermophyton floccosum
• Tinea cruris (jock itch) caused by T. rubrum and E. floccosum
• Tinea corporis (ringworm of the body) caused by T. rubrum and E. floccosum

Clinically Accepted Off-Label Uses:

• Tinea versicolor
• Candidal intertrigo (in select cases)
• Mild cases of onychomycosis (under specialist supervision)

Route: Topical application

Adults and Adolescents (≥12 years):

• Tinea cruris and tinea corporis: Apply a thin layer to the affected area once daily for 1 week.
• Tinea pedis: Apply a thin layer to the affected area once daily for 2 weeks.

Pediatrics (<12 years):

• Safety and efficacy not established.

Elderly:

• No dose adjustment required.

Renal/Hepatic Impairment:

• No dosage adjustment needed due to negligible systemic absorption.

Instructions:

• Apply to clean, dry, intact skin.
• Avoid use in eyes, mouth, or vagina.
• Wash hands after application.

Luliconazole is an imidazole antifungal agent that inhibits the fungal enzyme lanosterol 14α-demethylase, essential in the biosynthesis of ergosterol, a key component of fungal cell membranes. By disrupting ergosterol synthesis, luliconazole compromises fungal membrane integrity and function, leading to fungal cell death. It demonstrates potent fungicidal activity against dermatophytes with minimal systemic absorption.

• Absorption: Minimal systemic absorption following topical use.
• Distribution: Negligible; remains localized at the application site.
• Metabolism: Minor hepatic metabolism when absorbed; largely bypassed due to low systemic levels.
• Half-life: Not clinically relevant.
• Elimination: Excreted mostly unchanged through feces in trace amounts.
• Onset of Action: Symptomatic relief typically observed within 2–3 days of starting therapy.

Pregnancy:

• No FDA-assigned category.
• Animal studies have not shown fetal harm; human data lacking.
• Use during pregnancy only if clearly needed.

Lactation:

• Unknown if luliconazole is excreted in human breast milk.
• Due to negligible absorption, it is likely safe; avoid application to the breast area during nursing.

• Primary Class: Topical Antifungal
• Subclass: Imidazole derivative antifungal agent

• Hypersensitivity to luliconazole or any component of the formulation
• Use in or near the eyes, mouth, or intravaginally

• Local Irritation: Discontinue use if severe irritation, redness, or rash occurs.
• Systemic Fungal Infections: Not effective or recommended for systemic or deep fungal infections.
• Use in Children: Safety not established in patients below 12 years.
• Avoid Occlusion: Do not apply under occlusive dressings unless instructed.

Common (1–5%):

• Mild application site reactions (burning, stinging, redness, itching)

Uncommon (<1%):

• Allergic contact dermatitis
• Skin discoloration or dryness

Rare:

• Hypersensitivity reactions

Severity & Onset:

• Typically mild and localized; onset usually within first few days of use.

• No significant drug-drug interactions reported due to minimal systemic absorption.
• No CYP450-mediated interactions known.
• Use caution if applying concurrently with other topical products to avoid dilution or irritation.

• Recent FDA Reviews: Continued endorsement of once-daily short-duration regimens due to high efficacy.
• Clinical Guidelines: Included in dermatology treatment protocols for superficial dermatophytoses; favored for patient adherence due to once-daily dosing.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Humidity: Store in a dry area.
• Light Protection: Store in original container away from direct light.
• Handling Precautions: Do not freeze; for external use only; keep container tightly closed.